Characterisation of relative bioavailability of Diena (Test) in comparison to Valette® (Reference) after single dose administration under fasting conditions

Assessment of bioequivalence of Test vs. Reference after single dose administration under fasting conditions, determined by use of area under the concentration time curve AUC0-tlast and maximum concentration Cmax obtained for ethinylestradiol (EE) and dienogest (DNG)

Descriptive characterisation of safety and tolerability of the investigational products in the study population

presence or history of liver tumours or known or suspected sex-hormone influenced malignancies (e.g. of the breasts or endometrium)

unclarified vaginal bleeding or amenorrhoe

subjects with fructose or galactose intolerance, deficiency of lactase, saccharase-isomaltase or malabsortion of glucose/galactose Lack of suitability for the trial

acute or chronic diseases which could affect absorption or metabolism

history of or current drug or alcohol dependence

regular intake of alcoholic food or beverages of ≥ 20 g per day

subjects who are on a diet which could affect the pharmacokinetics of the active ingredient

regular intake of caffeine containing food or beverages of ≥ 500 mg per day

blood donation or other blood loss of more than 400 ml within the last two months prior to individual enrolment of the subject

participation in a clinical trial during the last two months prior to individual enrolment of the subject

regular treatment with any systemically available medication (except usual replacement therapy with L-thyroxine)

subjects, who report a frequent occurrence of migraine attacks

use of hormonal preparations within 6 weeks (oral, transdermal, vaginal), 2 months (intramuscularly administered depot preparations used once per month) or 6 months (intramuscularly administered depot preparations used once per 3 month) before pre-study examination

For female subjects with childbearing potential only:

positive pregnancy test at pre-study examination

pregnant or lactating women

female subjects who do not agree to apply adequate non-hormonal and highly effective contraceptive methods as defined in Note for Guidance on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals (CPMP/ICH/286/95, modification), November 2000 Administrative reasons

subjects suspected or known not to follow instructions

subjects who are unable to understand the written and verbal instructions, in particular regarding the risks and inconveniences they will be exposed to during their participation in the study The exclusion criteria are chosen to assure that subjects with specific risks for administration of the investigated medicinal products and subjects with conditions, which may have an impact on pharmacokinetic parameters, cannot be included.

Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.